Method and composition for the treatment of scars

ABSTRACT

A method and composition for treating healed wounds including hypertrophic scars so as to prevent scarring or reduce the size and improve the appearance of scars comprises applying to the healed wound or scar a composition comprising a fluid, film-forming carrier which may contain one or more active topical ingredients, the carrier hardening to a solid, tangible, membrane juxtaposed to the skin. Novel compositions using the film-forming carrier are also useful to treat a variety of adverse skin disorders, and internal physiological conditions.

RELATED PATENTS AND APPLICATIONS

This application is a division of U.S. Ser. No. 10/022,216, filed Dec.20, 2001 now abandoned, which is a continuation-in-part of U.S. Ser. No.09/441,138, filed Nov. 17, 1999, which is now U.S. Pat. No. 6,337,076,issued Jan. 8, 2002.

FIELD OF THE INVENTION

This invention relates to a method for the prevention or reduction ofscars, as well as for improving the size and appearance of scar tissue.The invention also relates to a novel topical composition for theprevention or reduction of scar formation and for the treatment of scarsand other skin conditions and diseases.

BACKGROUND OF THE INVENTION

When skin or dermis has been traumatized by cutting or burning, scartissue is formed. In most cases, a small cut or burn area will result ina correspondingly small amount of scar tissue which is not readilydiscernable to a casual observer. In other cases, where the traumatizedarea is large and/or lengthy, scarring and scar tissue are quiteapparent to a casual observer. This cannot only be embarrassing for theperson who is scarred, but can be a distraction for the casual observer.The problem is compounded when, over time, scar tissue tends to darken,become thick and project outwardly from the skin surface, thus becomingmore apparent.

In normal wound-healing or sore-healing processes, the abundant vascularnetwork is regenerated in the wound or the sore during the maturingphase and the collagen fibers collect in large bundles. Changingpatterns of the connective tissue matrix during growth, development, andrepair during the healing of a wound and sore require a delicate balancebetween the synthesis and degradation of collagen. Under normalcircumstances, the balance between the synthesis and degradation ofcollagen is maintained. However, sometimes this maturing process failsto occur, so that scar tissue remains beneath the covering epitheliumfor a relatively long period of time and may even develop and becomeenlarged. This is the clinical nature of a hypertrophic scar.

Although balanced scar formation and remodeling are essential processesin skin wound healing, disorders of excess scar formation remain acommon and therapeutically refractory clinical problem. A hypertrophicscar is an excessive scar which by definition has grown in size beyondthat required for normal wound healing. Hypertrophic scars can emergefrom many wound types, such as from a burn or a sharp incision. Ahypertrophic scar is a raised, red and itching enlargement. The scar maybe tender to the touch and to other external pressure and can form onevery afflicted part of the body.

Hypertrophic scars often remain for a very long time, sometimes throughthe entire life of the person so afflicted. A hypertrophic scar maytransform to a typical soft and pale scar after a year or so. Inaddition to itching and being relatively unsightly, if the hypertrophicscar happens to overlay a skeletal joint, movement of the joint is oftenpainful and restricted. In the past, such complications were overcome bycovering the scar tissue with clothing, makeup, or avoiding contact withother people. This strategy is often not possible nor desirable. Scartissue and the tissue adjacent thereto can often become hypersensitiveto contact with clothing, and often, a person will not cover the scartissue to the detriment of socialization. In some instances, a personmight not be able to tolerate the application of makeup over scartissue, again to the detriment of socialization. In other instances, aperson may be required to wear a certain type or style of clothing whichdoes not cover scar tissue locations.

Many medical care givers have recognized the problems associated withscar tissue and now include scar tissue management as part of theoverall treatment of patients.

A number of techniques have been proposed for the improvement of scars.These include the application of pressure and treatments such as withcorticosteroids, collagen, vitamins, such as vitamins E and A, andextracts from vegetable and animal sources. While some of thesetreatments have had modest success, all of the treatments can becumbersome, inconvenient or even painful.

The use of pressure dressings is believed to be the first trulyeffective scar treatment. Application of pressure apparently increasesthe activity of collagenase, which is an enzyme capable of degrading andmodeling the scar tissue and is employed by the body in the equilibriumof the formation and degradation of collagen during the healing process.However, pressure dressings are bulky rendering them uncomfortable tothe user and often inconvenient to keep in place on the affected scartissue.

The application of a steroid such as cortisone also increases thecollagen degradation activity of collagenase while decreasing irritationof the scar. With a large amount of extra scar tissue such as ahypertrophic scar or keloid, depending on the severity, a physicianoften recommends cortisone injections. In less severe cases, cortisonecreams or cortisone tapes do show modest benefit. However, creams areoften inconvenient to use as they are messy and can stick to anddiscolor clothing. The use of tapes are also disadvantageous as suchtapes often hold moisture and fall off the affected area. Further, thecortisone creams are required to be rubbed or massaged onto the scar.For some persons, this can be painful. Cortisone injections can also bevery painful to the patient.

Vitamin treatment such as vitamin E is believed to decrease theexpression of collagen forming genes during the wound healing processand also may soften scars. Cutting vitamin E gelatin capsules in halfand squeezing out the oil has been the most common way to apply vitaminE to wounds. Obviously, a vitamin E oil is messy and cutting thecapsules in half is a tedious process. The addition of vitamins A and Bin creams and lotions is also known, but such creams and lotions areoften oily to the touch and do not dry so as to remain in an oilycondition or take a long period of time to rub completely into the skin.Again, rubbing or massaging a cream or oil into and/or onto certain scartissue can be painful to some persons.

It has been discovered in recent years that the shrinkage ofhypertrophic scars can be increased by applying silicone-gel plates orsheets to the scars. The exact mechanism by which the silicone-gelinteracts with such scars has not been established, however. A number ofproducts are available commercially for this purpose, for instance suchproducts as Dow Corning Silastic Sheeting, Cica-Care (Smith & Nephew),Epi-Derm (Biodermis), Nagosil (Nagor), among others. These products havethe form of molded silicone-gel sheets having a thickness of 2-4millimeters. In treating hypertrophic scars, these sheets are placedover the scars and are worn for a relatively long period of time, oftenfrom 3-12 months, until the scars either have decreased or haveregenerated. Examples of recent patents which disclose such silicone-gelsheets include U.S. Pat. Nos. 5,759,560; 5,891,076; 5,895,656; and5,919,476.

The known silicone sheets are relatively rigid and after having beenplaced over the scar have insufficient adhesion to remain securely inposition without some form of assistance. Consequently, it is necessaryto secure the sheets against the skin with the aid of securing,stocking, bandage, self-adhesive tape or some like means. The sheets canoften trap too much moisture causing irritation on the affected area.Additionally, gel sheets of the type that utilize silicone are tacky tothe touch, both on the inner body, body contacting surface and theexterior surface. Having a body contacting surface which is tacky to thetouch is advantageous and desirable. However, having an exterior whichis tacky to the touch is not. A disadvantage of having a tacky exterioris that articles of clothing tend to adhere to the gel sheet. Thispresents several problems. One problem is that often the gel sheetadheres to an article of clothing with greater force than it adheres tothe skin. Thus, when the article of clothing is removed, the gel sheetis removed from the body. Another problem is that the articles ofclothing would adhere to the gel sheet and prevent normal range ofmotion. An additional problem encountered with gel sheets which aretacky to the touch is that they tend to become soiled more quickly.

Similar silicone materials in the form of topical gels, cremes, andointments are also available on the market for treatment of wounds, e.g.Kelocote.® Again, these materials remain greasy or oily on the skin andhave the disadvantages as described above with respect to comfort andsoiled clothing.

Other physical treatments are available, including surgery, X-raytherapy and cryotherapy. Such treatments are expensive or potentiallydangerous and not normally recommended.

Accordingly, while there have been physical treatments, compositionsand/or articles which contain medicaments which have had modest successin reducing, softening and lightening hypertrophic scars, these priorattempts are expensive, inconvenient to use, difficult to apply orsimply have not been very effective in achieving the desired purpose.

SUMMARY OF THE INVENTION

As expressed above, existing therapy for hypertrophic scars and keloidshas included surgery, mechanical pressure, X-ray irritation,cryotherapy, and the application of various medicaments such assteroids, vitamins, as well as vegetable and animal extracts. Again,there are many disadvantages associated with each of these methods.Thus, surgical removal of the scar tissue is often incomplete and canresult in the development of hypertrophic scars and keloids at theincision and suture points. X-ray therapy is the only predictablyeffective treatment to date, however, because of its potential forcausing cancer, X-ray therapy is not generally recommended or accepted.The most common approach to control hypertrophic scar and keloidformation is to apply pressure, which appears to be effective in manyinstances. However, this treatment has limited application, generallybased on the size and location of the scar tissue on the body. Steroidinjections are unpredictable and often result in depigmentation of theskin. Application of silicon-based gels such as in sheets has resultedin general improvement in the appearance and size of treated scars, butthe mechanism of such healing is not known and the inconvenience of suchsilicone-gel sheets has been discussed previously.

Accordingly, a primary objective of the present invention is to providean effective and, yet convenient to use composition which can prevent orreduce scarring of healed wounds or improve the size and appearance offormed scars, in particular, hypertrophic scars.

One aspect of the present invention is directed to a method for thetreatment of healed wounds or hypertrophic scars with a medicamentcapable of preventing scarring or reducing the size or improving theappearance of scars. The medicament is mixed within a film-formingcarrier which can be accurately and directly applied as a fluid to theaffected area, including scar tissue, and which results in the formationof a tangible membrane juxtaposed to the affected skin to hold themedicament in place. This tangible membrane differentiates from thecoating residue remaining after application of prior art ointments,gels, cremes, liquids or sprays. Such residues do not form a removablephysical lamina as in the present invention. A number of film-formingcarriers are known which dry in place and are not greasy or oily to thetouch after application and drying as has characterized carrierspreviously used with the application of vitamins or other vegetable oranimal extracts or with steroids. The film-forming carrier can beapplied directly onto the healed wound or formed scar to be treatedwithout the need for rubbing or the application of pressure such as withoily or greasy carriers which application can often be painful to theperson whose wound or scar is being treated.

In another aspect of the present invention, a composition is providedwhich is effective for reducing the size and appearance of scars and canbe readily and accurately applied directly to a healed wound or to ascar, such as a hypertrophic scar without the problems associated withoils and greases, or wraps and sheets, which have been used to merelyapply pressure or provide contact with silicone-gels. In this aspect ofthe invention, a composition is provided comprising a fluid,film-forming carrier which includes a dermatologically effective steroidsuch as a corticosteroid which can be applied directly onto the healedwound or the scar tissue and which carrier forms a tangible membranejuxtaposed to the affected tissue and which contains the steroidmedicament.

In an alternative to the invention described immediately above, asteroid, silicone-gel or vitamin E, or mixtures thereof are provided ina fluid, film-forming carrier as above described and which can be usedto treat not only wounds or scars but a variety of skin conditions anddisorders.

Another aspect of this invention is the use of a fluid, film-formingcarrier which forms a tangible membrane juxtaposed to the skin toadminister medicaments such as chemotherapeutic (anti-cancer) agents,analgesics, and other physiological-affecting agents topically orparenterally.

In still another aspect of the present invention, a composition for thetreatment of healed wounds or hypertrophic scars so as to preventscarring or reduce the size of the scar or improve the appearancethereof is provided by combining a dermatologically effective steroidsuch as, hydrocortisone, a silicone-gel and, optionally, vitamin E in asingle fluid carrier which can be applied directly to the wound or scartissue and presents for the first time a multicomponent medicamentcomposition combining the effective properties of components which havebeen used singly. It has been found that the steroid, silicone-gel andvitamin E can be effectively mixed within a fluid film-forming carrierand be applied directly to the wound or scar tissue in a convenientmanner. The composition hardens to a tangible membrane remainingjuxtaposed to the affected area without the need for wraps, tapes, andwithout the disadvantages of oils or greases which can discolor clothingand need to be rubbed or massaged onto and into the scar.

In yet another aspect of this invention, it has been found that theapplication of a film-forming composition as a fluid onto healed woundsor scars, and drying the composition to a tangible film juxtaposed onthe affected area, even without a medication therein, can be effectiveto reduce scarring due to the pressure which is applied onto wound orscar tissue when the solid film forms.

In still yet another aspect of this invention, a healed wound or scar istreated by the topical application of collagenase onto the affectedarea. The collagenase can be incorporated into the fluid, film-formingcarriers of this invention or any known topical or transdermal carrier,including ointment, cremes, gels and patches.

DETAILED DESCRIPTION OF THE INVENTION

The method of the present invention is directed to the application of amedicament contained in a fluid, film-forming carrier to the affectedwound or scar tissue. As described herein, the film-forming carrierrefers to a fluid film which results upon application to the skin in theformation of a tangible membrane juxtaposed to the skin surface. Thefilm-forming carrier contains one or more medicaments (activeingredients) which applied onto a healed wound or scar tissue and heldin place by the carrier film can prevent or reduce scar formation or canreduce the size of a hypertrophic scar and/or improve the appearancethereof. Thus, the method of the present invention is the application ofa fluid, film-former and one or more effective scar-treating medicamentsto a healed wound or hypertrophic scar. The film-former forms aprotective membrane over the site of application to maintain contact ofthe active ingredients with the wound or scar and prevents removal ofthe active ingredients from the site. In its broadest aspect, the filmforming carrier alone can provide effective scar treatment since whenthe carrier forms the tangible film, pressure is applied to the affectarea. The application of pressure is known to reduce scarring byincreasing the activity of collagenase as described previously. Thus theapplication of the carrier alone as a fluid without the need formassaging or rubbing the fluid onto the wound or scar and the drying orcuring of the carrier into a solid film as previously described providesa convenient, useful and effective scar prevention or scar reductiontreatment.

The method of this invention is directed to treatment of wounds such asformed as the result of accidental skin trauma, e.g. cuts, bruises,burns, or due to surgical procedures. The wounds to be treated should behealed, i.e. reepithelized such that the exterior dermis layer of thewound is intact. For example, a surgical wound can be treatedimmediately after surgical stitching has been removed, or an accidentalwound can be treated after it has reepithelized. Wounds can be treatedhours to several months after the trauma depending on the extent of thewound and the vascularity of the area wounded. It is believed the methodof this invention can prevent the formation of scarring by maintainingthe proper balance of collagen synthesis and degradation immediatelyafter reepithelization of the wound. In any event, scarring can bereduced by application to the healed wound of the medicament in thefilm-forming carrier. The method of this invention is also directed totreatment of scars which have already formed, such as hypertrophicscars. Reduction of hypertrophic scars and improvement in coloration andother appearance has been found with the method of this invention.

The film-formers which are preferably used in the method of the presentinvention are cellulosic derivatives such as methyl cellulose which canform films from aqueous solutions and nitrocellulose which can be usedin organic solvents. Collodion or Flexible Collodion are very usefulfluid, film-formers which can be used. Collodion is a solution of 4grams of pyroxylin (chiefly nitrocellulose) in 100 ml. of a mixture of25 milliliters alcohol and 75 milliliters ether. Collodion is acolorless or slightly yellow, clear or slightly opalescent syrupyliquid. The flexible Collodion comprises simple Collodion with theaddition of camphor and 3% castor oil (by weight). Flexible Collodion isslightly yellow and is a syrupy liquid which contains 67% either andabout 22% absolute alcohol by volume. When the Collodion or FlexibleCollodion evaporates it leaves a tough and colorless solid, tangiblefilm, not merely a coating residue as do previous carriers such asointments, cremes, gels, and the like. Polyvinylalcohol is also a usefulaqueous, film-forming carrier which can be used in this invention. Moregenerally, any film-forming carrier which can be applied to the affectedarea as a fluid regardless of viscosity and dries or otherwise cures toa solid, non-greasy or non-oily, tangible membrane film can be usedalone or with other medicaments to prevent or reduce scarring. Siliconeresins which are fluid but cure to solid films in air such as thosehaving the consistency of caulking, as well as other polymers are usefulin this invention. The topical compositions of the invention may alsocontain a solvent added to the carrier which serves to reduce carrierviscosity and/or dissolve the active ingredient. Examples of solventswhich may be used include water and organic solvents such as acetone,alcoholic or ethers.

In the preferred method of this invention, an active ingredient which iseffective to prevent or reduce scar formation or to treat hypertrophicscars is included in the film-forming carrier. Any active ingredientwhich is so effective, known or unknown at the present time, is usefulin the method of this invention. Such active ingredients includedermatologically active steroids, e.g. corticosteroids, vitamins andother vegetable and animal extracts known to treat scars, as well assilicones, including silicone-gels which have been used in silicone-gelsheets and plates.

Another active which can be used is the enzyme collagenase. Enzymes areproteinaceous substances which act as catalysts for biologicalreactions; in some cases hydrolysis reactions and in othersoxidation-reduction processes. Some enzymes have broad activity andothers, such as collagenase (Clostridiopeptidase A) produced from thebacterium clostridium hystolyticum, have very specific activity. Highlypurified collagenase has been prepared and been found uniquely capableof cleaving bonds in the collagen structure permitting other enzymes toact on the resulting molecular fragments. Purified collagenase has beendemonstrated to be relatively safe even in large doses (thousands ofunits) in animals and in contact with human blood vessels, nerves andbones.

In preparing topical compositions for use in the method of thisinvention, there can be added conventional adjuvants such as propionicacid, propylene glycol, acetone and lactic acid, conventionalpenetration enhancers such as erucic acid, oleic acid and bahemic acid;conventional buffers, preservatives, hydrophilic emulsifiers, lipophilicemulsifiers, sun-screening agents, perfumes, emollients, deodorants,humectants, and the like. Colorants may also optionally be added in theuseful compositions of the invention. Current Collodion-based FDAmonograph approved formulas may be employed in such topical liquidcompositions.

Preferably, in the method of this invention, the composition is appliedto a healed wound or to the scar tissue to be treated by any commonapplicator such as a brush, roll, squeeze tube, sprayer or eye droppingapparatus conveniently used to apply compositions to the skin. Thecompositions may also be applied by impregnating a porous base with thecomposition and wiping the composition onto the affected area or wherethe porous base includes an adhesive, securing the porous base to theskin adjacent to the wound or scar and wherein the film-former andactive ingredient are placed on the area to be treated. The compositionused in the method of the present invention can be a relatively low orhigh viscous liquid which can be applied directly and accurately ontothe wound or scar tissue and does not require the application ofadditional pressure or rubbing as do certain oils and greases which havebeen previously utilized. Accordingly, it is believed that the use of afilm-former, which forms a tangible, solid film with optionally one ormore medicaments to treat healed wounds or hypertrophic scars is novel.

In another aspect of the present invention, a composition is provided totreat wounds or hypertrophic scars so as to prevent scar formation orreduce the size of the scars and improve the appearance thereof. In thisaspect of the invention, an active ingredient in the form of a steroidis added to the film-forming carrier. Thus, it has been found thatdermatologically active steroids which an be applied topically, such ashydrocortisone, betamethasone, diflusinol and any other knowncorticosteroids and the like, as well as pharmaceutically acceptablesalts thereof including chloride, acetate, etc., can be added to thefilm-forming carrier in amounts of from about 0.01% to about 70% byweight to yield a composition which can be readily and directly appliedto the affected tissue. The composition forms a solid, tangible film asabove described which maintains the steroid active ingredient juxtaposedto the wound or scar tissue and provides an advantageous and continuoushealing effect of the steroid. As previously disclosed, adjuvantstypically used for topical compositions can be added, includingsolvents, penetration enhancers, emollients, buffers, etc. as long assuch addition does not adversely interfere with the effectiveness of thesteroid.

The present invention provides a further composition which is useful toprevent scarring or to improve the size and appearance of hypertrophicscars. The composition again is based upon the film-forming carrier. Inthis aspect of the invention, two or more medicaments which are activeto improve hypertrophic scars and which have been used on a individualbasis are now combined in the film-forming carrier which forms a solidfilm on the affected area and provides a base from which the actives canact upon the healed wound or the scar tissue and provide the desiredimprovement. Thus, in accordance with this invention, the carrier hasincorporated therein at least one dermatologically active steroid, asilicone-gel and, optionally, vitamin E.

The dermatologically active steroid which can be used is that describedabove, in particular, corticosteroids such as hydrocortisone,betamethasone, diflusinol and the like, including pharmaceuticallyacceptable salts thereof.

Additionally, it has been found that the carrier can still remainfilm-forming and a particularly advantageous composition can be formedby the addition of silicone to the composition either alone or inaddition to the dermatologically active steroid. The silicones which canbe added to the composition of this invention are those which have beenfound effective to improve the appearance and size of hypertrophicscars. Silicones are a group of completely synthetic polymers containingthe recurring group —SiR₂O— wherein R is a radical such as an alkyl,phenyl, or vinyl group which may be substituted or unsubstituted. Thesimpler silicones are oils of very low melting point, while at the otherend of the scale of physical properties are highly cross-linkedsilicones which form rigid solids. Intermediate physical properties aresilicone elastomers such as gels and rubbers. A variety of silicone-gelshave been used as wound dressings as disclosed in U.S. Pat. No.4,838,253 assigned to Johnson and Johnson and U.S. Pat. No. 4,991,574assigned to Dow. An example of a useful silicone-gel which has been usedis marketed under the tradename SILASTIC®.

While it has not been proven conclusively as to how the silicone-gelsact on the scar tissue to improve them, based n experiments involvingthe measurement of physical parameters associated with the use of suchgels, investigators have concluded that the mode of operation of thesilicone-gel and scar treatment did not involve pressure, temperature,oxygen, tension or occlusion. Rather, as reported, the likely mechanismsinvolved both hydration of the stratum corneum and the release of a lowmolecular weight silicone fluid from the gel.

Any of the known silicone-gels which have been previously used for wounddressings as described above can be used as additives in the compositionof this invention. In general, the silicone-gel will have a viscosity at25° C. of about 25-30,000 cps, preferably 100-30,000 cps. A phenyltrimethicone such as Dow Corning 556 fluid or a non-volatilepolydimethylsiloxane are examples of silicone fluids which can be used.

Although optional, it is preferred to include any one or more forms ofvitamin E to the composition. In this most preferred embodiment, threeactive ingredients which have been known to treat hypertrophic scars onan individual basis have been found to be extremely useful in combinedform in a single film-forming carrier without disadvantageousinteractions between the components. Useful compositions can comprisefrom about 0.01-70% by weight of the steroid, preferably from about0.05-10% of the steroid; 0.01-70%, preferably 5-25% silicone and 0-25%,preferably 0.1 to 25% vitamin E. The balance is the film-formingcarrier, such as listed previously.

Compositions of this invention have been found useful when applied onceor twice daily for 3-4 months to yield the best results of softening,shrinking and lightening hypertrophic scars. Less dosing to preventhealed wounds from scarring may be needed.

As previously stated, other adjuvants can be added to enhancepenetration of the active ingredients, control moisture levels on thescar tissue, provide preservative and antibacterial effects, etc. Inanother preferred embodiment, small amounts of xanthan gum can be addedwhich provides both thickening qualities and acts as a dispersionenhancer for the active ingredients, including the steroids such ashydrocortisone and the silicone component. If xanthan gum is added, itshould be present in amounts of from about 0.5-4%, preferably from about0.75-2.5% by weight.

The invention is still further directed to a topical composition whichcan be used to readily and effectively treat a variety of adverse skinconditions, including hypertrophic scars, eczema, psoriasis, atopicdermatitis, insect bites, poison ivy and like plant toxins, and otherinfectious and immunological skin disorders. In this aspect of theinvention, topical actives such as steroids, including corticosteroids,silicone-gels, i.e. non-volatile polysiloxanes, vitamins, includingvitamins A and E, or mixtures thereof, are incorporated into thefilm-forming carrier of this invention and which forms a non-sticky ornon-greasy tangible film on the skin surface. The levels of each activecomponent will vary depending on the skin disorder being treated and canbe readily determined from known usages of the actives which have beencontained in other carriers such as lotions, greases, oil or porousstructures, e.g. bandages, gauze, etc. In general, levels of 0.01 wt. %to 75 wt. % are most practical but, variations are acceptable within thescope of this invention.

The film-forming carriers of the present invention may also be used totopically and parenterally deliver medications which have beenpreviously applied by injection or transdermally such as by physicalpatches or even orally. Thus, film-forming carriers of this inventioncan contain such medicaments such as chemotherapeutic agents which canbe applied to the skin to topically treat skin cancers or form areservoir which when applied to the skin can transdermally direct themedicament to the underlying tissue and the blood stream. Likewise,analgesics such as topical anesthetics as well as parenteral and orallyactive analgesics can be transdermally administered utilizing thefilm-forming carrier of this invention. Still further, vasodilators,bronchial dilators, antihistamines, such as benadryl or the like,addictive suppression agents or other therapies such as nicotine can betopically applied for transdermal application using the film-formingcarriers of this invention. Any other medicament which has an internalphysiological affect and can be otherwise transdermally administered canbe incorporated in the fluid, film-forming carriers of this inventionand conveniently administered to the patient by simply applying thecomposition to the skin. The film-forming carrier containing thetherapeutic agent dries or otherwise cures to a tangible membrane whichholds the medicament in contact with the skin. Levels of active in thefluid, film-forming carrier of this invention will obviously varydepending on the type of agent and can be determined by those skilled inthe art. The fluid carriers of this invention allow for rapid and easyapplication of the active, such as by any known fluid applicator.Moreover, the active can be administered by a single application orreapplied subsequent to hardening of the carrier with or without removalof the underlying film.

The compositions of the present invention are believed to be novel.Film-forming materials alone or containing a steroid and/or siliconehave not been used to treat healed wounds or hypertrophic scars. Whilehydrocortisone is available as a topical ointment or cream and siliconeis available as a liquid, an ointment or as a bandage sheet that must becut and adhered to the skin with tape or other mechanism, thecomposition of the present invention can combine one or both of theseactive agents or include any of the topically active or internalphysiologically active therapeutic agents discussed previously anddispense such agents into a matrix of an occlusive dressing that whenbrushed or otherwise applied onto the skin as a fluid, dries orotherwise cures quickly to solid form, keeps the active ingredients incontact with the skin to exert their intended action, and may be peeledoff, either at completion of therapy or to apply subsequent doses. Thecompositions of this invention require no mechanical aid, i.e. adhesivebandage, gauze or impregnated sheet coverings. Application is simplyaccomplished by directing the fluid base, preferably medicated, onto theaffected area and allowing to harden. The liquid base fully hardens,creating a solid, flexible occlusive bandage covering. While thecompositions can be easily brushed on, other applicators can be usedincluding a dispensing-type device which will roll the material onto theaffected area, extrude the composition such as from a tube, as well asapply from spray-type devices or eye dropper-type mechanisms for lessviscous composition. What is important is that the carrier of thisinvention does not need to be rubbed or massaged onto the affected areawhich can be painful in certain circumstances. Further, the carrierhardens to a solid film which will not stick to clothing.

EXAMPLE 1

The following composition was prepared as a scar-healing composition.The composition was prepared by adding the ingredients shown to thecarrier base, which in this instance was Flexible Collodion, USP.

-   10 wt. % silicone 556-   1 wt. % hydrocortisone hydrochloride-   0.5% alpha-tocopherol (vitamin E)-   1.2 wt. % xanthan gum-   balance of Flexible Collodion, USP

EXAMPLE 2

An alternative formulation was prepared that did not include the xanthangum.

-   12 wt. % silicone 556-   0.5 wt. % hydrocortisone hydrochloride-   0.5 wt. % vitamin E-   balance Flexible Collodion, LTSP

EXAMPLE 3

The following composition is useful for applying a topical anesthetic.

-   98 wt. % Flexible Collodion-   2 wt. % Lidocaine

The Examples are not intended to strictly limit the invention to theembodiments shown. It should be understood that the foregoing detaileddescription is given merely by way of illustration. Obviously, manymodifications and variations of the invention as hereinbefore set forthcan be made without departing from the spirit and scope thereof, andtherefore, only such limitations should be imposed as are indicated bythe appended claims.

1. A method of treating healed wounds so as to reduce scarring and/orimprove the appearance of scars comprises; applying onto a healed wounda composition comprising a fluid, film-forming carrier, and subsequentlyhardening the carrier into a tangible membrane juxtaposed to the healedwound thereby reducing scarring or improving the appearance thereof. 2.The method of claim 1, wherein the film-forming carrier comprisesCollodion or Flexible Collodion.
 3. The method of claim 1, wherein saidcomposition is applied onto the healed wound by brushing, rolling,extruding or applying drops of said composition.
 4. The method of claim3, wherein said composition is applied to the healed wound by brushing.5. The method of claim 1, wherein said composition includes an activeingredient capable of reducing scarring or improving the appearance ofscars selected from a topical steroid, silicone-gel, vitamin andmixtures thereof.
 6. The method of claim 5, wherein said activeingredient includes a corticosteroid or a pharmaceutically acceptablesalt thereof.
 7. The method of claim 5, wherein said active ingredientcomprises a combination of a topical steroid and silicone-gel.
 8. Themethod of claim 5, wherein said active ingredient is a silicone-gel. 9.The method of claim 7, wherein said composition further includes vitaminE.
 10. The method of claim 1, wherein said film-forming carrier is acellulosic derivative.
 11. The method of claim 10, wherein saidcellulosic derivative is nitrocellulose.
 12. The method of claim 10,wherein said cellulosic derivative is methyl cellulose.
 13. The methodof claim 1, wherein said film-forming carrier comprises a siliconeresin.
 14. The method of claim 1, wherein said healed wound comprises ahypertrophic scar.
 15. The method of claim 1, wherein said healed woundis one formed after surgery.
 16. The method of claim 1, wherein saidhealed wound is formed after accidental trauma.
 17. A method of treatinghealed wounds so as to reduce scarring and/or improve the appearance ofscars comprises: applying onto a healed wound a topical compositioncomprising collagenase.
 18. The method of claim 17, wherein said topicalcomposition comprises collagenase contained within a fluid, film-formingcarrier, subsequent to applying said composition onto said healed wound,hardening said carrier into a tangible membrane juxtaposed to the healedwound.
 19. The method of claim 17, wherein said topical compositioncomprises collagenase contained within a topical creme, ointment, lotionor gel.